By-pass line connector for compounding system

ABSTRACT

A method for selectively dispensing fluid components through a bypass, the bypass having a fluid passage with an inlet, a first outlet that is unsealed, and a second outlet that is sealed, includes the steps of inserting a tubing line into the second outlet to unseal the second outlet, sealing the first outlet to prevent flow of fluid through the first outlet, and delivering a first fluid component into the inlet of the bypass and through the second outlet.

RELATED APPLICATION

This divisional application is being filed in accordance with 35 U.S.C.§121 and claims priority to U.S. patent application Ser. No. 10/942,529,filed Sep. 16, 2004, the entire contents of which is incorporated byreference herein.

FIELD OF THE INVENTION

The present invention relates generally to compounder systems, and moreparticularly, to a compounder system having a bypass for transferringdifferent types of solutions into separated chambers of a receivingreceptacle.

BACKGROUND OF THE INVENTION

Hyperalimentation therapy is the intravenous feeding of nutrients topatients. A typical solution would include a protein-carbohydratemixture. It is used primarily to meet the patient's protein and caloricrequirements that are unable to be satisfied by oral feeding. Theprotein may be in the form of free-amino acids or protein hydrolysateand the carbohydrate commonly is dextrose. In addition to the proteinand carbohydrate, vitamins (water-soluble and fat-soluble) andelectrolytes also can be supplied in this therapy.

Each of these parenteral ingredients and the combination thereof areparticularly susceptible to the growth of deleterious organisms and itis desirable that they be administered to the patient in a sterilecondition. In addition, the solutions are tailor made to specificpatient requirements under the direction of a physician. Thus, becausethese protein and carbohydrate solutions must be combined close, butprior, to their time of use, their compounding must be performed understerile conditions to avoid organism growth.

As a part of this compounding, the solutions that are to be administeredintravenously are transferred into a total parental nutrition bag(commonly referred to as a TPN bag). Such bags are designed for home useor use in a hospital or care facility. Once filled they can be storedfor a limited period of time in a standard refrigerator. The bags arefilled with the solutions by a pharmacist either by gravity or by adevice known as a high speed bulk compounder. Such compounders typicallyare capable of supplying solutions from up to nine different source bags(and possibly more) or containers to a receiving product bag atrelatively high flow rates.

The source containers may be hung from a framework of the compounderwhile the receiving bag is hung from a load cell that measures theweight of the receiving bag. A pump set consisting of a number of pumplegs (for example, nine or more such legs) or flow paths is designed tobe used with the compounder. Each of the pump legs includes flexibletubing and terminates on one end with a piercing administration spike orsimilar connector that is used to connect the leg of the pump set to oneof the source containers. The other end of each leg is coupled to one ofthe inlet ports of a common manifold equipped with an exit port that isadapted to be coupled to a fill tubing connected to the receiving TPNproduct bag.

In those instances where a high-speed compounder is used, each leg ofthe pump set is associated with a different peristaltic pump or pumpstation of the compounder. A microprocessor in the compounder controlseach of the peristaltic pumps or pump stations to thereby control theamount of solution being supplied from each source container through theparticular pump leg and the manifold to the receiving product bag. Theamount of solution being supplied from each source container is in partdetermined by information being supplied to the microprocessor of theweight being measured at selected times by the load cell from which thereceiving bag is suspended. The peristaltic pumps draw solutions fromeach of the source containers sequentially under the control of themicroprocessor and the solutions flow through the common manifold andthe fill tubing into the receiving product bag.

A problem arises when one of the fluids to be introduced into theproduct bag is a lipid solution. Lipid solutions are essentially fatemulsions and typically are placed into a separate compartment withinthe product bag which is isolated from the remaining mixture untilimmediately before (or very soon before) the solution is administered toa patient. This isolation is necessary because the lipid solution, ifmixed with the other ingredients ahead of time, clouds the overallsolution mixture and renders it unusable. This phenomena is known in theart as “hazing.” Because of the undesirability of mixing lipids with theother solutions prior to the time of administration, a problem hasexisted in the prior art where a residual amount of the lipid solutionis allowed to remain in a common volume of the manifold after a lipidsolution is pumped through but before the next non-lipid solution ispumped through. When the subsequent solution is pumped through, theresidual lipid solution is carried into the product bag and hazingresults.

One solution has involved the use of a chambered product bag. By pumpingthe lipids into a separate chamber of the product bag, the lipids willnot mix and “haze” the solution. Immediately before the solution isused, the separated chamber with the lipids is allowed to mix with theremaining solution to form the product solution. To fill the chamberedbag using conventional compounders, one line of the compounder must bedevoted specifically for lipids and be attached directly to theseparated chamber of the product bag. By using the compounder in thismanner, however, one line is not used if the overall solution does notrequire a lipid component.

SUMMARY OF THE INVENTION

The present invention is directed to a tube set for dispensingcomponents into a product bag. The tube set comprises a plurality oftubing lines, a manifold, and a bypass. The manifold has a plurality ofinlets, each inlet adapted for connection to a respective tubing line.The manifold also has an outlet connectable to a first feed tube of aproduct bag. The bypass is associated with at least one of the pluralityof tubing lines. The bypass has a bypass inlet connectable to the tubingline associated with the bypass. The bypass also has at least twooutlets. A first outlet is connected to a tube line in fluidcommunication with an inlet of the manifold and a second outlet isremovably connectable to a second feed line in fluid communication withthe product bag.

According to another embodiment, the present invention is directed to abypass for a tube set. The tube set includes a manifold and a pluralityof tubing lines for dispensing fluid components into a product bag. Thebypass comprises an inlet fluid passage adapted for connection to atubing line of the tube set, an outlet adapted to receive a tubing linein fluid communication with the product bag, and a bypass fluid passageadapted for connection to a tubing line in fluid communication with themanifold. The bypass is configured such that fluid enters the bypassinlet fluid passage and exits through the outlet only when the outlet isconnected to a tubing line in direct fluid communication with theproduct bag.

An exemplary method of the present invention is a method for selectivelydispensing fluid components into a product bag attached to a tube set ofa bulk compounder. The bulk compounder includes a product bag attachedto a tube set having a plurality of tube lines, a manifold, and a bypasshaving a fluid passage with an inlet and at least two outlets. Themethod includes providing liquid components to be dispensed into theproduct bag with one of the liquid components to be maintainedseparately from the other liquid components, inserting a tube line influid communication with the product bag into the bypass first outlet,blocking the bypass second outlet in fluid communication to themanifold, and dispensing the fluid component to be maintained separatefrom the other liquid components through the bypass and into the productbag, independent of the manifold.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exemplary bulk compouder having a bypass accordingto an embodiment of the invention;

FIG. 2 illustrates an exemplary bypass according to another exemplaryembodiment of the present invention; and

FIG. 3 is an enlarged view of an exemplary bypass according to thepresent invention.

DETAILED DESCRIPTION OF THE INVENTION

Although the invention is illustrated and described herein withreference to specific embodiments, the invention is not intended to belimited to the details shown. Rather, various modifications may be madein the details within the scope and range of equivalents of the claimsand without departing from the invention.

Referring to the Figures where like numerals represent like features,FIG. 1 shows a pharmaceutical compounding system 10. System 10 can beused for mixing or compounding two or more selected liquids and/or drugsintended to be administered to a human being or an animal. In use,system 10 serves to transfer two or more of individual prescribedliquids and/or drugs from multiple source containers (e.g., individualvials, bottles, syringes, or bags) into a single collecting container(e.g., a bottle, syringe, or bag), so that the mix of liquids and/ordrugs can be administered (e.g., intravenously) to an individual inneed.

As one example, due to injury, disease, or trauma, a patient may need toreceive all or some of his or her nutritional requirementsintravenously. In this situation, the patient will typically receive abasic solution containing a mixture of amino acids, dextrose, and fatemulsions, which provide a major portion of the patient's nutritionalneeds, which is called total parenteral nutrition, or, in shorthand,TPN. In this arrangement, a physician will prescribe a mixture of aminoacids, dextrose, and fat emulsions to be administered, as well as thefrequency of administration. To maintain a patient for an extendedperiod of time on TPN, smaller volumes of additional additives, such asvitamins, minerals, electrolytes, etc., are also prescribed forinclusion in the mix. Using system 10, under the supervision of apharmacist, the prescription order is entered and individual doses ofthe prescribed liquids, drugs, and/or additives are accordinglytransferred from separate individual source containers for mixing in asingle container for administration to the individual.

There are other environments where system 10 is well suited for use. Forexample, in the medical field, system 10 can be used to compound liquidsand/or drugs in support of chemotherapy, cardioplegia, therapiesinvolving the administration of antibiotics and/or blood productstherapies, and in biotechnology processing, including diagnosticsolution preparation and solution preparation for cellular and molecularprocess development. Furthermore, system 10 can be used to compoundliquids outside the medical field.

Tube set 15 is a part of system 10. Tube set 15 includes lengths oftransfer tubing line 20, which are joined at one end to a commonmanifold 45. At the opposite ends of the transfer tubing 15 are spikesor releasable couplings 100. Couplings 100 can be inserted inconventional fashion through a diaphragm carried by the associatedsource solution container (not shown), which allows flow communicationbetween the source solution container and the respective transfer tubingline 20. From manifold 45, a first feed line 50 is coupled to a productbag 80. As shown in the embodiment of FIG. 1, product bag 80 has twocompartments, a lower compartment 70 in connection with first line 50,and an upper compartment 65 in connection with a second feed line 60.Transfer tubing lines 20, first feed line 50, and second feed line 60can be made from flexible, medical grade plastic material, such aspolyvinyl chloride plasticized with di-2-ethylhexyl-phthalate. Likewise,product bag 80 can be made from a flexible, medical grade plastic,semi-rigid plastic or glass.

FIG. 1 illustrates system 10 having a bypass 23 for directing liquidsthrough manifold 45 or directly to upper compartment 65 of product bag80 by way of second feed line 60. As discussed above, once the lipidsolutions are mixed with other types of solutions, the shelf life forthe mixed solution (i.e., the amount of time before the solution needsto be used) is relatively short. Thus, there is a need to preparedual-chambered bags having lipid solution dispensed into one compartmentof the dual chambered product bag without wasting a tubing line orwithout the added need for a complete separate transfer tube line.

FIG. 2 illustrates an embodiment of bypass 23 of system 10. Bypass 23has inlet 25 of inlet fluid passage 220, which can be adapted for fluidcommunication with transfer tubing line 20 (not shown in FIG. 2).Connected to inlet fluid passage 220 is bypass fluid passage 200 forminga three-way junction at outlet 30. Bypass fluid passage 200 also hasoutlet 35 for connection with a tubing line (not shown in FIG. 2) to bein fluid communication with manifold 45. Alternatively, bypass 23 can bedescribed as having an inlet connectable to at least one tubing line 20and two outlets, where one of the outlets is connectable to a tube influid communication with an inlet of manifold 45. The second outlet isremovably connectable to second feed line 60 of product bag 80.

Also shown in FIG. 2 is flip-top cap 33 which is adapted to cover outlet30 when second feed line 60 is not connected to outlet 30. Disposedwithin outlet 30 is a resealable membrane 210 that is self-sealable whenpunctured, such as a diaphragm valve. Membrane 210 allows a male portionof first feed line 60 to be inserted into outlet 30. Membrane 210prevents fluids traveling through bypass 23 from escaping. Althoughmembrane 210 is described as a membrane, it can be a washer or othersuitable device that would prevent fluid from escaping the connectionbetween second feed line 60 and outlet 30 as would be understood by oneskilled in the art.

FIG. 3 is an enlarged and partially cut-away view of inlet fluid passage220 and bypass fluid passage 200 at outlet 30 with second feed line 60inserted into outlet 30. According to this embodiment, second feed line60 has a male connector at the end which meets bypass 23 at bypassoutlet 30, which is a female end. In the embodiment shown in FIG. 3, themale end of second feed line 60 is a hollow penetrating probe 230 thatpierces membrane 210. As probe 230 is fully inserted into outlet 30,probe 230 seals bypass fluid passage 200 from inlet fluid passage 220.By sealing or blocking bypass fluid passage 200, fluids flow into inletfluid passage 220 and into second feed line 60. The other end of secondfeed line 60 is adapted for connection to upper compartment 65 ofcompartmentalized product bag 80 as shown in FIG. 1. Likewise, whenprobe 230 of second feed line 60 is removed from outlet 30, resealablemembrane 210 closes and fluid flows from inlet fluid passage 220 throughto bypass fluid passage 200. Bypass fluid passage 200 is in fluidcommunication with manifold 45 by way of a bypass to manifold tubingline 40 (shown in FIG. 1).

As shown in the embodiment of FIG. 3, bypass 23 is shaped similar to a“y”. Bypass 23 is a three-way connector and may also be shaped like a“T”. Between inlet fluid passage 220 and bypass fluid passage 200 is theangle θ. Angle θ can be greater than 0° to less than 180°, preferableless than 90°. According to the embodiment shown in FIG. 3, angle θ is45°.

Referring again to FIG. 1, fluid components from tube set 15 connectedto individual fluid bottles (not shown) through couplings 100, deliverliquids that flow to manifold 45 and through first feed line 50 intoproduct bag 80. When a composition of liquids calls for a component thatmust be maintained separate until just before use, one tube line 20 fromtube set 15 is connected to inlet 25 of bypass 23. A second feed line 60is connected to outlet 30 of bypass 23. Second feed line 60 is in directfluid communication with upper compartment 65 of product bag 80. In thisconfiguration, the liquid to be maintained separate will flow throughtube line 20 connected to bypass 23 and exit outlet 30 connected tosecond feed line 60 as shown by line A. In this configuration, the fluid(e.g. a lipid solution) will not pass through manifold 45 andprematurely mix with the other liquid components, but rather willdirectly flow to upper chamber 65 of product bag 80 independent ofmanifold 45.

When a lipid solution is not used in the formulation, i.e., whencomponents of the liquid need not remain separate from the othercomponents, second feed line 60 may be removed from bypass 23. Thus, theliquid in the tube line connected to bypass inlet 25 will flow to bypass23 and will exit via bypass fluid passage 200, which is connected viatubing 40 to manifold 45. The fluid flow direction is shown by line B inFIG. 1. Once the fluid enters manifold 45, it exits manifold 45 by wayof first feed line 50, common to the other tubing lines 20, and flowsinto lower compartment 70 of product bag 80.

According to an embodiment of the present invention, tube set 15connected to manifold 45 and bypass 23 can be fabricated independentlyand joined together to form a single device made up of these individualcomponents. Preferably, these components can be ultrasonically welded totheir respective mate. The means of joining the components are discussedin detail below. The primary advantage to such a construction is ease ofmanufacture.

Bypass 23 could be made from any of a number of suitable materials,including plastics, such as polycarbonates, that are suitable to handlethe pharmaceutical and food preparations that will be passingtherethrough. The suitable materials should also preferably be such thatthey can be injection molded to form the parts of the device, or thewhole device, and one skilled in the art would know such materials.

While preferred embodiments of the invention have been shown anddescribed herein, it will be understood that such embodiments areprovided by way of example only. Numerous variations, changes andsubstitutions will occur to those skilled in the art without departingfrom the spirit of the invention. Accordingly, it is intended that theappended claims cover all such variations as fall within the spirit andscope of the invention.

1. A method for selectively dispensing fluid components into a productbag attached to a tube set of a bulk compounder having at least onetubing line, a manifold, and a bypass having a fluid passage with aninlet, a first outlet in fluid communication with the manifold, and asecond outlet in fluid communication with the product bag, the methodcomprising the steps of: providing liquid components to be dispensedinto a product bag wherein one of the liquid components is maintainedseparate from the other liquid components; inserting a tubing line influid communication with the product bag into the second outlet;blocking the first outlet in fluid communication to the manifold; anddispensing a fluid component to be maintained separate from the otherliquid components through the second outlet and into the product bag,independent of the manifold.
 2. The method of claim 1, wherein the stepof blocking the first outlet in fluid communication to the manifoldcomprises inserting a hollow probe end of the tubing line into the fluidpassage and past the first outlet such that the probe end obstructs thefirst outlet and prevents fluid from flowing from the inlet to the firstoutlet.
 3. The method of claim 1, wherein the liquid component to bemaintained separate is a lipid solution.
 4. The method of claim 1,wherein the step of inserting a tubing line into the second outlet,comprises opening a flow control device of the second outlet.
 5. Amethod for selectively dispensing fluid components into a product bagattached to a tube set of a bulk compounder having at least one tubingline, a manifold, and a bypass having a fluid passage with an inlet andat least two outlets, the method comprising the steps of: providingliquid components to be dispensed into a product bag; inserting a tubingline in fluid communication with the product bag into the second outlet;blocking the first outlet in fluid communication to the manifold; anddispensing a fluid component through the second outlet and into theproduct bag, independent of the manifold.
 6. The method of claim 5,wherein the step of blocking the first outlet in fluid communication tothe manifold comprises inserting a hollow probe end of the tubing lineinto the fluid passage and past the first outlet such that the probe endobstructs the first outlet and prevents fluid from flowing from theinlet to the first outlet.
 7. The method of claim 5, further comprisingthe steps of: removing the tubing line in fluid communication with theproduct bag from the second outlet; blocking the second outlet;unblocking the first outlet in fluid communication to the manifold; anddispensing the fluid component through the first outlet and manifold. 8.The method of claim 7, wherein the step of blocking the second outletcomprises sealing a membrane of the second outlet.
 9. The method ofclaim 7, wherein the step of blocking the second outlet comprisescovering the second outlet with a flip-top cap.
 10. The method of claim7, wherein the step of unblocking the first outlet is completed by thestep of removing the tubing line from the second outlet.
 11. A methodfor selectively dispensing fluid components through a bypass, the bypasshaving a fluid passage with an inlet, a first outlet in fluidcommunication with a first bag compartment, and a second outlet that issealed: inserting a tubing line into the second outlet to unseal thesecond outlet; connecting the tubing line in fluid communication with asecond bag compartment that is fluidly separate from the first bagcompartment; sealing the first outlet to prevent flow of fluid to thefirst bag compartment; and delivering a first fluid component into theinlet of the bypass and through the second outlet to the second bagcompartment.
 12. The method of claim 11, wherein the step of sealing thefirst outlet is completed by the step of inserting a tubing line intothe second outlet.
 13. The method of claim 11 further comprising thesteps of: stopping delivery of the first fluid component into the inletof the bypass; removing the tubing line from the second outlet; sealingthe second outlet to prevent flow of fluid to the second bagcompartment; unsealing the first outlet; and delivering a second fluidcomponent into the inlet of the bypass and through the first outlet tothe first bag compartment.
 14. The method of claim 13, wherein the stepof sealing the second outlet is completed by the step of removing thetubing line from the second outlet.
 15. The method of claim 13, whereinthe steps of sealing the second outlet to prevent flow of fluid to thesecond bag compartment and unsealing the first outlet are both completedby the step of removing the tubing line from the second outlet.
 16. Themethod of claim 11 wherein the first bag compartment and second bagcompartment are located in the same fluid bag.